 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: - Today, the FDA approved a new indication for Olumiant (baricitinib) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval. The FDA first issued an emergency use authorization (EUA) for Olumiant in combination with remdesivir to treat COVID-19 in hospitalized adults and pediatric patients on November 19, 2020. On July 28, 2021, the FDA revised the EUA to authorize Olumiant as a standalone treatment. Olumiant remains under EUA status for hospitalized pediatric patients 2 to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The FDA has revised the Letter of Authorization and associated fact sheets to remove the population covered under the approved indication. Common side effects of Olumiant and the recommended dosage for the approved population are included in the prescribing information. The FDA continues to work with developers, researchers, manufacturers, and partners to help expedite the development and availability of therapeutic drugs and biological products to prevent or treat COVID-19 through its Coronavirus Treatment Acceleration Program.
- Today, the FDA issued a safety communication warning people to not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the tests work correctly. SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold), and the FDA has identified this issue as a Class I recall, the most serious type of recall.
- Today, the FDA posted the refreshed Consumer Update titled Is It Really 'FDA Approved'? This article highlights the many ways the FDA is responsible for protecting the public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
- On Monday, the FDA posted warning letters to multiple companies for selling adulterated dietary supplements that contain, in some cases, new dietary ingredients (NDIs) for which the FDA has not received the required premarket NDI notifications and, in others, unsafe food additives. Some of the identified dietary supplements also are drugs, despite lacking approval, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. These products could potentially harm consumers.
- On Monday, the FDA issued draft guidance for industry (GFI) #272, which compiles and describes established practices that medicated feed manufacturers can use to prevent contamination of animal food from unsafe drug carryover into other batches of medicated feed or non-medicated animal food. The FDA will be accepting public comments on the draft guidance through August 8, 2022. When finalized, GFI #272 will not change the substance of existing policies or introduce new policies. Rather, it will consolidate much of the information found in two outdated Compliance Policy Guides and include current animal food regulatory information and updated examples of factors to consider when designing sequencing practices.
- COVID-19 testing updates:
- As of today, 433 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests, and 1 diagnostic breath test. There are 77 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home
- The FDA has authorized 28 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 968 revisions to EUA authorizations
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